Colorectal Carcinoma Metastatic in the LiverNCT05059717
An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases
A study testing Magnetic Resonance Imaging in people with Colorectal Carcinoma Metastatic in the Liver, run by M.D. Anderson Cancer Center.
Trial summary
This trial studies how well a magnetic resonance imaging technique called Displacement Encoding with Stimulated Echo (DENSE) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma Metastatic in the Liver
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2018to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy.
- No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
- Patient who is able to undergo informed consent.
- Men and non-pregnant women.
- Metastatic disease limited to liver.
- Metastases involving no more than 6 liver segments.
- No radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
Who cannot join
- Contraindication to MRI.
- Inability to comply with study and/or follow-up procedures.
- Unable to provide informed consent.
- Presence of extrahepatic metastatic disease.
- Metastases involving more than 6 liver segments.
- Radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
- Pregnant women.
About this study
Official title: Imaging Tissue Motion Using MR Displacement Encoding With Stimulated Echo (DENSE): Detection of Early Chemotherapy Related Liver Injury Prior to Resection of Colorectal Liver Metastases
This trial studies how well a magnetic resonance imaging technique called Displacement Encoding with Stimulated Echo (DENSE) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. Researchers want to learn if the DENSE technique improves the standard MRI method.
Read the detailed description
PRIMARY OBJECTIVE:
- This is an exploratory study to collect Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
SECONDARY OBJECTIVES:
- Estimate sensitivity of MR DENSE (determine degree of 2 dimensional [2D] vector displacement with cardiac cycle and variability of measurements with cardiac ventricle contraction).
II. Determine detection of sinusoidal injury (sinusoidal fibrosis, necrosis of pericentral hepatocytes, narrowing and fibrosis of central veins) on biopsy with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.
III. Determine correlation of intra-operative surgical scores (liver color and texture) with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.
OUTLINE:
Patients undergo standard of care magnetic resonance imaging (MRI) and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences.
- Being tested
- Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo standard of care MRI
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MR DENSE imaging
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (standard of care MRI, MR DENSE MRI) | Experimental | Patients undergo standard of care MRI and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences. Receives: Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
Measured: through study completion, an average of a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start12 Jul 2018
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Why it stopped: Overall Recruitment Status Withdrawn no participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Carcinoma Metastatic in the LiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Priya Bhosale, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059717
- Sponsor's protocol ID
- 2016-1115
- Other IDs
- NCI-2019-02483, 2016-1115
- Status last verified
- Nov 2023
- First submitted
- 9 Sep 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Tissue Motion Using MR Displacement Encoding With Stimulated Echo (DENSE): Detection of Early Chemotherapy Related Liver Injury Prior to Resection of Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT05059717
- Acronym / sponsor ID
- 2016-1115
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Overall Recruitment Status Withdrawn no participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well a magnetic resonance imaging technique called Displacement Encoding with Stimulated Echo (DENSE) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. Researchers want to learn if the DENSE technique improves the standard MRI method.
Detailed description
PRIMARY OBJECTIVE:
- This is an exploratory study to collect Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
SECONDARY OBJECTIVES:
- Estimate sensitivity of MR DENSE (determine degree of 2 dimensional [2D] vector displacement with cardiac cycle and variability of measurements with cardiac ventricle contraction).
II. Determine detection of sinusoidal injury (sinusoidal fibrosis, necrosis of pericentral hepatocytes, narrowing and fibrosis of central veins) on biopsy with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.
III. Determine correlation of intra-operative surgical scores (liver color and texture) with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.
OUTLINE:
Patients undergo standard of care magnetic resonance imaging (MRI) and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (standard of care MRI, MR DENSE MRI) | Experimental | Procedure: Magnetic Resonance ImagingPatients undergo standard of care MRI and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy.
- No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
- Patient who is able to undergo informed consent.
- Men and non-pregnant women.
- Metastatic disease limited to liver.
Key exclusion criteria (7 listed)
- Contraindication to MRI.
- Inability to comply with study and/or follow-up procedures.
- Unable to provide informed consent.
- Presence of extrahepatic metastatic disease.
- Metastases involving more than 6 liver segments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo standard of care MRI | Procedure or surgery | Diagnostic (standard of care MRI, MR DENSE MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MR DENSE imaging | Procedure or surgery | Diagnostic (standard of care MRI, MR DENSE MRI) |
Primary outcome
Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
Time frame: through study completion, an average of a year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priya Bhosale principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Colorectal Carcinoma Metastatic in the Liver, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury. (time frame: through study completion, an average of a year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.